TMINI Miniature Robotic System

K243481

THINK Surgical, Inc. · cleared 2025-01-06 · product code OLO · Neurology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“The TMINI® Miniature Robotic System like its predicate, the TMINI® Miniature Robotic System consists of three primary components: a three-dimensional, graphical, Preoperative Planning Workstation (TPLAN Planning Station), an Optical Tracking Navigation Console (TNav) and a robotically controlled hand-held tool (TMINI Robot) that assists the surgeon in preparing the bone for implantation of TKA components. In addition, this submission will add a web-based method for surgeons to review, approve and download approved surgical plans generated on the TPLAN Planning Station. The TPLAN® Planning Station component of the TMINI® Miniature Robotic System has been modified to improve the segmentation algorithm using a pre-trained and closed machine learning model during the development, enhance DICOM data importing, update the implant display and selection tools, and improve cybersecurity.”
Algorithmpre-trained and closed machine learning model for segmentation
source quote (p.5)
“The TPLAN® Planning Station component of the TMINI® Miniature Robotic System has been modified to improve the segmentation algorithm using a pre-trained and closed machine learning model during the development, enhance DICOM data importing, update the implant display and selection tools, and improve cybersecurity.”
Adaptive (vs locked)No
source quote (p.5)
“The TPLAN® Planning Station component of the TMINI® Miniature Robotic System has been modified to improve the segmentation algorithm using a pre-trained and closed machine learning model during the development, enhance DICOM data importing, update the implant display and selection tools, and improve cybersecurity.”
PCCPNo
Cybersecurity addressedYes
source quote (p.5)
“The TPLAN® Planning Station component of the TMINI® Miniature Robotic System has been modified to improve the segmentation algorithm using a pre-trained and closed machine learning model during the development, enhance DICOM data importing, update the implant display and selection tools, and improve cybersecurity.”

Validation studies (1)

Bench

sample size not stated

endpoints: Full System Run Through Testing; Cutting Accuracy; Pin & Block Placement Accuracy; Cadaver Lab Validation Testing; System Gap Balance Accuracy; User Needs Validation Testing; Usability Testing; Software Testing; Biocompatibility Testing

standards: ISO 14971:2019

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

25
recalls in product code, 24mo
2666
MAUDE reports in code, 12mo
+26%
vs code's own 3-yr baseline
5
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K250877 (decision 2025-06-20) from THINK Surgical, Inc. for a matching device line ("TMINI Miniature Robotic System") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K250877

  • recall_reason_pattern

    Software/algorithm-related recall in product code OLO (, initiated 2025-12-10): "Software errors that can result in incorrect surgical instrument positioning during spinal surgery." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98199

  • recall_reason_pattern

    Software/algorithm-related recall in product code OLO (Tornier S.A.S. 161 Rue Lavoisier Montbonnot-Saint-Martin France, initiated 2025-03-05): "Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance proh" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:96437

  • recall_reason_pattern

    Software/algorithm-related recall in product code OLO (Medtronic Navigation, Inc., initiated 2024-08-22): "Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orientation - when lateral orientation radiographic images are taken, informat" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:95283

  • recall_reason_pattern

    Software/algorithm-related recall in product code OLO (, initiated 2024-07-17): "Software anomalies which can result in two separate issues: A lagging screen display during a navigated procedure; or the potential for a mismatch between the navigated screw and t" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:95189

Recalls attributed to this device

  • Recalling firm matches this device's applicant (Think Surgical, Inc.) — same firm and product code, not necessarily this device · initiated 2024-02-12

    There is a galling effect (cold-weld) caused by friction between the array fixation pins and the TMINI array guide holes due to insufficient clearance between the outer diameter of the fixation pins and the inner diameter of the TMINI array guide holes. As a result, the array guide has the possibility of binding to the array fixation pins during drilling.

    recall event 94086 (openFDA)

  • Recalling firm matches this device's applicant (Think Surgical, Inc.) — same firm and product code, not necessarily this device · initiated 2018-03-30

    There is a potential for the cutter head to detach from the cutter shaft.

    recall event 80091 (openFDA)

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Neurology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K243481